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The Controversy Reignites

By Joseph Mercola, DO

Vitamin K shots are routine for most newborns… but the practice has its dark side.

The controversy surrounding administering vitamin K shots to newborns recently surfaced when physicians at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tennessee, reported seeing a rise in late-onset vitamin K deficiency bleeding (VKDB) in young infants.

The rise is blamed on increasing numbers of parents declining to have their babies receive a vitamin K shot at birth—a routine practice in the United States since 1961. In a Pediatric Neurology article, the researchers call for a state and national tracking system to monitor how many infants are getting the vitamin K shot at birth.

Writing for Mother Jones, Chris Mooney cites an article I wrote in 2010 in which I recommend giving an oral dose of vitamin K instead of an injection. The article in question was actually an interview with Cees Vermeer, Ph.D., who is generally recognized as the leading vitamin K expert in the world.

Mooney lambasts me for raising questions about the safety of vaccinations, and weaves together a picture in which parents who are cautious about vaccines— courtesy of my awareness-raising campaign—also take issue with vitamin K injections.

His tone doesn’t surprise me. What many people probably don’t know is that Chris Mooney is a welldocumented skeptic who worked for the Center for Inquiry, an organization whose founder, Paul Kurtz, has even criticized, stating, “I consider them atheist fundamentalists.”

For those who are not aware, the “skeptics” are a small but well-organized group that appear to despise alternative medicine and consider it to be similar to a religion, where belief trumps science. They have been quite aggressive in attacking doctors who practice alternative medicine for many years.

Kurtz goes on to say, “They’re anti-religious, and they’re mean-spirited, unfortunately. Now, [there are] very good atheists and very dedicated people who do not believe in God. But you have this aggressive and militant phase of atheism, and that does more damage than good.”

Mooney also produces a very dogmatic podcast, and some comments in the resulting storm have gone so far as to say I’m guilty of infanticide and should be in jail— all because I suggest vitamin K is likely to be better given orally instead of via injection.

Is the vitamin K injection the best way to prevent vitamin K deficiency bleeding? Vitamin K is not a blood coagulant in and of itself, as Mooney incorrectly states, but it is an important catalyst in the coagulation cascade. Without vitamin K, the coagulation cascade stops before the clot forms.

When this occurs in infants, they can develop uncontrolled bleeding anywhere in their body, including the brain. There are three basic categories of VKDB, classified according to age at onset:

Early onset: Within the first day of life. Early VKDB is exceedingly rare, and is typically related to medicines used by the mother that inhibit vitamin K activity.

Classic: Within the first week of life. This is the most common form, occurring in 0.25–1.5 percent of infants who have not received vitamin K at birth.

Late onset: From the second week of life up to six months of age. Occurs in 5 to 7 out of every 100,000 infants not given prophylactic vitamin K, and is indicative of inadequate intake of vitamin K, malabsorption issues, and/or impaired utilization due to an underlying liver disorder.

While vitamin K is important to prevent brain bleeding in newborns, I strongly believe there are safer and non-invasive ways to normalize an infant’s vitamin K levels that don’t require a potentially traumatic injection given in massive mega-dose quantities. The amount of vitamin K injected into newborns is 20,000 times the newborn’s typical level at birth. It seems most odd that conventional medicine repeatedly warns against megadosing vitamins in adults, yet doesn’t raise any questions at all about the practice of giving a massive dose of a synthetic vitamin to an hours-old infant.

Also, infants are more or less universally born with low vitamin K levels. Is it then really reasonable to categorize it as a true deficiency state? Might there be a fundamental biological reason for being born with an initially low vitamin K level?

The truth is, we don’t know. Researchers determined that giving vitamin K at birth worked to virtually eliminate hemorrhaging, and that more or less marked the end of the thought process.

Besides the question of whether or not a one-time mega-dose is the most appropriate route, the vitamin K injection also contains potentially toxic additives like aluminum. Many experts believe that aluminum is more toxic than mercury.

The injection is also loaded with preservatives, such as polysorbate 80 (known as Tween 80, which has estrogenic effects) and propylene glycol (a skin irritant).

As explained by Dr. Natasha Campbell-McBride, the introduction of toxins in combination with poor gut flora (a problem that affects a great number of infants these days) can lead to developmental problems. It doesn’t matter where these toxins come from—ideally, you’d want to avoid exposing your infant to any.

Injection Is Not Risk-Free

As noted in a 2001 article in Pediatric Pharmacotherapy, the standard practice in the U.S. is to administer an intra-muscular injection of 0.5–1 milligram (mg) of phytonadione within one hour of birth. Phytonadione is a fat-soluble synthetic vitamin K1 analog.

Ironically, the phytonadione drug insert warns that it can cause severe, sometimes fatal, allergic reactions when injected into a muscle or vein, and is ideally taken by mouth or injected under the skin. Signs of an allergic reaction include hives, trouble breathing, and swelling of the face, lips, tongue or throat.

One recent PLOS ONE study looking into this issue found that allergic reactions appear to be linked to the preservatives in the vitamin K1 injection:

[S]erious anaphylaxis-like symptoms appeared in beagle dogs after the administration of vitamin K1 injection for the first time. The plasma histamine concentration increased, and blood pressure decreased sharply. After sensitization, dogs were challenged with vitamin K1 injection and displayed the same degree of symptoms as prior to sensitization. However, when the vitamin K1 injection-sensitized dogs were challenged with a vitamin K1-fat emulsion without solubilizers such as Tween-80, the abnormal reactions did not occur…

Our results indicate that the adverse reaction induced by vitamin K1 injection is an anaphylactoid reaction, not anaphylaxis. Vitamin K1 injection induces the release of inflammatory factors via a non-IgE-mediated immune pathway, for which the trigger may be the solubilizer.

Even more ironic, pregnant women are warned that it is not known whether phytonadione might harm their baby if taken during pregnancy or while breastfeeding. The recommended daily allowance (RDA) for infants 0–6 months is 2 micrograms (mcg) per day, so with the shot they are receiving a dose that is 5,000 times the RDA.

The RDA for adult women is 90 mcg/day. If you’re an adult suffering minor bleeding due to warfarin use, a one-time dose of 2.5–5 mg is recommended. If an adult overdoses on phytonadione, they’re advised to call Poison Control. And yet newborn babies are given a 1 mg injection, whether they need it or not. This is a highly irrational approach, any way you look at it. It’s simply not supported by the science in any way, shape or form.

The Case for Oral K1 Supplementation

As noted in Pediatric Pharmacotherapy:

Oral vitamin K administration would appear to offer several advantages for routine VKDB prophylaxis…. It has been suggested that longer regimens of oral vitamin K would prevent late VKDB while avoiding the concerns with IM [intramuscular] use. In 1992, The Netherlands adopted a regimen of 1 mg oral vitamin K at birth, followed by daily doses of 25 mcg from 1 week to 3 months of age in breastfed infants.

Surveillance data collected on infants receiving this regimen have revealed no cases of late VKDB. Another alternative regimen now used in Switzerland consists of weekly 1 mg oral doses for two or three months with the Konakion MM preparation [an alternative vitamin K preparation by Roche]. The primary disadvantages of these methods are the reliance on parent compliance. Giving an oral vitamin should not be looked at as so difficult, especially with the frequency of pediatric visits.

The paper also notes that: “It is clear that oral administration of vitamin K produces adequate serum concentrations for the prevention of classic VKDB. While no oral liquid preparation is available in the United States, the injectable product has been found to be safe and effective when given by the oral route.” Again, there was not one single episode of VKDB in infants given the oral dose. The concerns that Mooney brings up about the increase in VKDB are clearly related to noncompliance with the oral route, not to its efficacy.

To me, it appears obvious that if the U.S. made an oral vitamin K1 supplement to be taken for the first three months of life, that would be the safest method to avoid vitamin K deficient bleeding in infants. Not only should vitamin K1 be given orally, but vitamin D and vitamin K2 should be as well, since most parents are so adamant about shielding their children from the sun. As a result of this widespread sun-phobia, most children are vitamin D deficient from birth. According to one recent study, breastfed infants should ideally begin receiving vitamin D supplementation at birth. The study supports using a dose of 400 IUs (international units) of vitamin D per day for the first nine months of the baby’s life.